The biopharmaceutical sector is stumbling through the early months of 2022, as investors appear to be pulling back from the enthusiasm that marked much of the last two years. BioWorld’s Biopharmaceutical Index (BBI) is down 4.2% through last week and the Nasdaq Biotechnology Index shows a drop of more than 15%, while the Dow Jones Industrial Average (DJIA) has likewise fallen 5.58%. In contrast, BBI had a 10.5% gain in 2020 and a 5.93% gain in 2021. While each of those years represent the top two years for financings in the history of the industry, 2022 appears to be lagging in that regard as well, with January financings down by 55% over the prior year. Read More
LONDON – Targed Biopharmaceuticals BV has raised €39 million (US$44.2 million) in a series A financing that will enable it to take its targeted clot busting drug Microlyse into clinical development. The first-in-class product consists of urokinase, a serine protease involved in the conversion of inactive plasminogen to active plasmin, linked to a nanobody targeted at von Willebrand factor, the blood glycoprotein that plays a key role in hemostasis. Read More
Biontech SE and Medigene AG have signed a three-year research collaboration to develop T-cell receptor (TCR) based immunotherapies against cancer. Medigene will receive €26 million ($29.5 million) up front and could receive hundreds of millions of euros per drug in milestone payments from the deal, which will also covers research funding for the period of the collaboration. Read More
Shares in Synairgen plc have cratered after a phase III trial of its inhaled COVID-19 therapy SNG-001 failed to produce conclusive results, with the company blaming improvements in standard care for the disappointing findings in patients hospitalized with the disease. The Southampton, U.K.-based biotech’s shares (LSE:SNG) touched lows of 10 pence, down 94%, and stabilized around 85% below their previous closing price of £25.36 after the announcement on Monday. Read More
China is the latest country mixing things up when it comes to COVID-19 boosters. Since boosters were implemented in China in October, adults have been given a third dose of their primary vaccine regimen, which has consisted of one of three inactivated vaccines produced by Sinopharm Group Co. Ltd. and Sinovac Biotech Ltd. Read More
Jubilant Therapeutics Inc. started 2022 with an IND clearance for JBI-802, its oral, selective dual inhibitor of lysine-specific demethylase 1 (LSD1) and HDAC6, setting up a year that could be important for LSD1 in the hands of others as well. Read More
Paving the way for wider dissemination of up-to-date information on drugs approved in the EU, the European Medicines Regulatory Network adopted a common standard for the electronic product information (EPI), which includes the package leaflet for patients and the summary of product characteristics for health care professionals. Read More
Once again, the U.S. FDA is calling out Cytodyn Inc. for promoting its investigational new drug, leronlimab, as safe and effective against COVID-19. Read More
The CDC’s Advisory Committee on Immunization Practices (ACIP) always had a full schedule, but COVID-19 amped it up. William Schaffner, who joined ACIP in 1982, talks with BioWorld's Lee Landenberger about the committee and how it makes the big decisions that affect public health policy. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Biomarin, Dizal, Novavax, Ose, Transthera, UCB, Veloxis. Read More
